Safety and effectiveness of lurasidone for the treatment of schizophrenia in Asian patients: Results of a 26‐week open‐label extension study

This study was designed to evaluate the long‐term safety and effectiveness of lurasidone in the treatment of schizophrenia among Asian patients. Methods Patients (N = 281) with schizophrenia who had completed a randomized, double‐blind (DB), 6‐week comparison of lurasidone (40 and 80 mg/day) and placebo were enrolled in a 26‐week extension study in which all patients received open‐label (OL), flexible doses of lurasidone (40 or 80 mg/day). Effectiveness was measured using the Positive and Negative Syndrome Scale (PANSS) scale. Results Fifty‐seven percent of patients completed the OL extension study; 16.7% discontinued early due to lack of effectiveness; and 10.3% due to adverse events. The most common adverse events were insomnia (11.3%), akathisia (11.0%), and nasopharyngitis (10.6%). Adverse events related to weight gain, metabolic parameters, prolactin, and ECG measures were uncommon. Mean change in the PANSS total score from the DB baseline to OL endpoint was −28.4, with mean improvement of −7.5 observed from baseline to OL endpoint, and with a PANSS responder rate of 73.7%. Discussion The results of the current 26‐week extension study found lurasidone to be a generally safe, well‐tolerated, and effective long‐term treatment for schizophrenia in Asian patients.